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Description of key information

The potential of surface treated carbon black (XPB 295) to induce and elicit delayed hypersensitivity was tested in guinea pigs using the Buehler method (in accordance with the OECD test guideline 406) and GLP conditions (Degussa AG 2003). A group of 20 test animals was induced by topical application of a 50% aqueous suspension of the test material once a week for three weeks and challenged two weeks later with the same test concentration. Application sites showed dark coloration, but none of the treated animals had a sensitisation reaction. A “reliability check” was performed in parallel to the afore mentioned study in a group of animals with alpha-cinnamic aldehyde. 60% of this group showed a sensitisation reaction, and the test system was therefore considered to be valid. The study is reliable without restrictions (reliability code 1).

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
04/2003 to 10/2003
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
Study performed before adoption of the OECD TG 429 (LLNA method)
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
in accordance with the OECD/EU testing guideline 406
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
epidermal induction with 50% of the test material in sterile water
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
50% of the test material in sterile water
No. of animals per dose:
20 animals in the test group, 10 animals in the control group
Details on study design:
in accordance with the OECD/EU testing guidelines
Challenge controls:
in accordance with the OECD/EU testing guidelines
Positive control substance(s):
yes
Remarks:
alpha-hexylcinnamaldehyde
Positive control results:
60% response
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% in sterile water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
dark coloration of treatment sites
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50% in sterile water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
dark coloration of treatment sites
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
α-Hexylcinnamaldehyde
No. with + reactions:
6
Total no. in group:
10
Clinical observations:
sensitisation effects in 6/10
Remarks on result:
positive indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
Carbon Black XPB 295 was not sensitising in guinea pigs (Buehler test performed according to OECD guideline 406)
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In humans, no cases of allergies have been reported to the responsible occupational physicians within the carbon black manufacturing industry (ICBA 2016).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available
Additional information:

Surface treated carbon black has not been tested in animals for sensitisation effects on the respiratory tract.

Justification for classification or non-classification

Not classifiable according to the criteria as laid down in the CLP Regulation